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Online Resumes with "FDA Compliance"
I am interested in making contributions to your enterprise as a Product Manager, Engineering Manager, Director of Operations. I have a wealth of experience in New Product Development, Current Products Engineering, Industrial & Manufacturing Engineering - Steel Manufacturing, Steel Tube Manufacturing, Lean Process Improvement Design & Implementation - Operations Capacity Planning - Facility Layout Design - Production Contro...
Tags for this Online Resume: Continuous Improvment
Senior Level Technician managing teams and optimizing autonomous tasks with precision. Brilliant technical leader delivers shareholder value to the most prestigious global organizations.
Professional with exemplary record in providing Packaging Lines/Process Systems in support of new product presentations and product launches, and improving packaging line and process system efficiencies utilizing Six Sigma Lean Manufacturing concepts. As an astute and organized problem-solver creating solutions and bringing together various groups to have a common consensus and agreement.
Summary Qualified manufacturing supervisor with 10 years production experience, professionally skilled in leading high productive team, using lean manufacturing principles to reduce cost and increase process efficiency. In-depth knowledge of cGMP regulation and FDA compliance. Dedicated leader with demonstrated ability to train, manage and motivate team members to achieve organization goals and objective. Accomplishments Pl...
Ideal Companies: A growing or prominent biopharmacuetical company. Gilead, Amgen, Roche, Kite, Novartis
Tags for this Online Resume: Management, Quality, Quality Assurance, Quality Control, Inventory, Manufacturing, Corrective Actions, Lean Manufacturing, Production Planing, ISO 8 environment, Chaired Daily QIT meetings
To gain a position wherein my training expertise, organizational and computer skills will be utilized effectively as an asset to overall organization.
Tags for this Online Resume: Documentation, Pharmaceutical experience, software support , FDA compliance , pre-clinical, Documentum, regulatory, LMS, Applications, Integrate, Lotus, Lotus Notes, Microsoft Frontpage, Microsoft Office, Microsoft Project, Electronic Publisher
PROFILE: With over 20 years in supervisory management and individual contributor positions within the Quality discipline, and 15 years with Customer Service; I have a total of 35 years of cGMP/GxP industry knowledge working within both in Commercial and Development environments (Virtual). My career spans both the Quality and Customer Service arenas and is supported by my skills in chemistry, mathematics, and business. My ex...
PROFILE: 8+ years of success in biologic research, data analysis, project management and leadership, scientific writing and editing, teaching and mentorship, and collaborative biomedical-based engineering in university and lab settings. * 6 research publications, highlighting advancements in bone tissue engineering and biopharmaceutical delivery. * Podium presentations at seminars and conferences focusing on scientific netw...
Tags for this Online Resume: Manufacturing, OSHA, Research, Cellular, Good Manufacturing Practices, Project Management, Project Manager, Biomedical Engineering, Materials Science, Biomaterials, Science, Biomedical, Pharmaceutical, Cell culture, Scaramento, Tissue engineering, Tissue culture, Laboratory
QUALIFICATIONS Blood Banking * Hematology * Chemistry * HIV Testing * Herpes Antigen Testing * Toxicology * Serology * Syphilis Testing * Cytomegalovirus (CMV) * Quality Control Experience * Quality Assurances * Procedures & Documentation * Knowledge of CAP, CLIA and FDA Compliance and Guidelines * Lab Testing & Reporting.
Tags for this Online Resume: Compliance, Documentation, Good Laboratory Practices, HIV/CMV/ABO/Rh, Medical Analysis, Occupational Safety and Health Act, OSHA, OSHA Regulations, Quality Control, Chemistry
Areas of expertise: Product Development - Outside Sourcing - Vendor Relation Interaction - Suppliers Interactions - Management - Personal Development Growth of Team Members- Quality Systems Consultation - Strategic Planning - Deviation Investigation - FDA Compliance - Root Cause Analysis - Budgeting Needs Assessment - Customer Service - Process Improvement & Optimization -Quality Assurance -Project Management - Audits Produ...
SUMMARY * 17 years of experience in pharmaceutical, Medical Devices, and FDA regulated environment including Quality Assurance and Process Computer System Validation. * Experience in generating all validation documents, including Validation Plan (MVP), Gap Analysis, Design Specifications, IQ, OQ, and PQ Test Protocols, Standard Operating Procedures (SOPs), and Validation Summary Reports. * Experience in Manufacturing Proces...
SUMMARY An analytical and detail-oriented healthcare professional, with extensive experience in nursing, biotechnology, regulatory compliance, global safety, pre- and post-market studies, research and development, clinical trials and FDA compliance. Utilizes exceptional organization and communication skills to consistently set and meet high-quality standards. Possesses a proven ability to utilize a cross-functional skill se...
SUMMARY Seeking Challenging Scientific /Engineering role with Chemical Engineering, Business Management degrees and 25+ years experiences in process/project/manufacturing/quality engineering in Fortune 500 companies in the United States. * Excel in process technologies for extrusion & molding of plastic & rubber manufacturing. * Experienced (hands on) in: Medical Equipment, Automotive, Rubber Compounding, Plastic, Glass, Fl...